Kornimate/medical-research-clean huggingface dataset:
patient knowledge, beliefs and barriers to hepatitis d care

Conditions: Hepatitis, Delta

Summary: a project to understand the determinants of health behaviour among those with chronic hepatitis d virus (hdv) infection, under the care of the viral hepatitis service at kings college hospital (kch). this is to improve and implement pathways and patient information distribution to improve access to care in an ethnically diverse population living with hdv in the uk. kings college hospital nhs foundation trust is uniquely placed and serves a large diverse population from areas such as pan pacific asia, eastern europe and regions in africa, where english is not their first language. this diversity is also seen in other london hospitals but less so in other parts of the uk.

to understand the knowledge patients have around their diagnosis of hepatitis d which is considered a rare disease but the most aggressive form of viral hepatitis. in order to improve the management of hepatitis d, this research aims to identify the current knowledge patients have about their diagnosis, the information provided to them in their preferred language, how they feel about their diagnosis and the stigma attached. this research has been conducted in patients with other forms of viral hepatitis but not in patients living with hepatitis d. there is a lack of research in this area. with this research we aim to improve treatment pathways, access to care and to information.

Eligibility criteria:
inclusion criteria: * participants 18 years or older. * hdv infection as diagnosed by high levels of anti-hdv immunoglobulin g (igg) and immunoglobulin m (igm), and confirmed by detection of hdv rna in serum. * treated hdv infection * willing and able to provide written informed consent. exclusion criteria: * clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.
effectiveness and cost-effectiveness of the initial medication adherence intervention

Conditions: Adherence, Medication

Summary: the purpose of this study is to assess the effectiveness and the cost-effectiveness of the initial medication adherence (ima) intervention.

a pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the ima intervention in comparison to usual care, in the increase of initiation of medicines for cvd and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in primary care (pc). the impact of the ima intervention on secondary adherence and clinical indicators will be evaluated. a multicenter pragmatic rct, with cluster allocation and 2 parallel branches (ima intervention vs. usual care) based on health records or rwd will be conducted. pc centres' personnel, including general practitioners (gp), nurses and community pharmacists, from different areas around catalonia (spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of pc centre, either rural or urban and taking into consideration the size and localization of the pc centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the pc centre). the ima intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. pc centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the ima website.

Eligibility criteria:
inclusion criteria: * primary care health professionals and pharmacists who: * agree to participate in the clinical trial and process evaluation. * attend the training course * are not plannig to be on sick leave during the study period (e.g. maternity leave). * patients who: * are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial. * are \>18 years old * do not reject to participate

Keywords: complex intervention real world data cardiovascular disease diabetes mellitus
use of liquid stable levothyroxine in trisomy 21 pediatric patients

Conditions: Hypothyroidism; Trisomy 21

Summary: children with levothyroxine (t21) have developmental delay and other functional gastrointestinal (gi) issues that may negatively affect l-t4 tolerability and absorption. for an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. for this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. we propose that tirosint-sol® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to l-t4 tablets.

hypothyroidism is a common medical disorder in children with trisomy 21 (t21). treatment with oral tablet levothyroxine (l-t4) is primarily used to treat this condition. however, children with t21 have developmental delay and other functional gastrointestinal (gi) issues that may negatively affect l-t4 tolerability and absorption. for an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. for this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. until recently, there was no liquid preparation of l-t4 in the united states for use in children. tirosint-sol® (liquid stable l-t4) is now fda-approved for use in children. the investigator proposes that tirosint-sol® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to l-t4 tablets.

Eligibility criteria:
inclusion criteria: * trisomy 21 children age 2 months to less than 5 years of age * prior confirmed diagnosis of congenital or acquired hypothyroidism exclusion criteria: * gestational age ≤ 35 weeks, concomitant anticonvulsant medications, history of nonadherence with medication or medical visit schedule * subjects must be able to take oral medication, no g-tube or parental fed subjects

Keywords: tolerability adherence
influence of biopsy technique on moleculargenetic tumor characterisation in nsclc

Conditions: Carcinoma, Non-Small-Cell Lung; Pathology, Molecular

Summary: study design prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of nsclc. patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients. objectives primary objective: assessment of differences in detection of molecular genetic alterations in nsclc between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy secondary objective: assessment of differences in detection of molecular genetic alterations in nsclc between * liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by tbna * combination of methods (tissue biopsy, tbna and liquid biopsy) and single techniques * naïve and processed tumor tissue specimen (eg. microdissection) to assess differences in side effects e.g. periinterventional bleeding explorative objective: to explore tumor mutational burden with regard to * solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy * cytologic material by (ebus-guided) tbna * liquid biopsy target subject population patients with suspected lung cancer or proven nsclc and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent to the study and the study specific procedures prior to any study intervention 2. male or female patients aged ≥18 years 3. patients with primary diagnosis of suspected lung cancer or patients with known nsclc and suspected relapse after therapy 4. bronchoscopically visible tumor exclusion criteria: 1. preexisting malignancy other than nsclc 2. contraindication for bronchoscopy according to the international guidelines, daily clinical practice and the local regulations with * patients with existing or at risk of pulmonary and cardiovascular decompensation * patients at increased risk of bleeding with antiplatelet agents except of aspirin (clopidogrel, ticlopidine, ...) , anticoagulant therapy (prolonged ptt), thrombocytopenia (\< 50.000/ul) or coagulopathy (prolonged in vitro bleeding time). * intolerance to sedation * unstable or immobile cervical spine * limited motion of the temporomandibular joint 3. previous enrolment in the present study
prevention of lymphoceles after robotic plnd

Conditions: Lymphoceles; Prostate Cancer

Summary: the endowrist one vessel sealer is a bipolar electrosurgical instrument for use with the da vinci si robotic surgical system. it is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. their use in this study will be to perform tissue transection during plnd such that the intended use is within the fda-approved domain for this instrument. investigators intend to identify whether its use for plnd reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during plnd. because the instrument is new and has been fda approved for less than one year, there is no published literature regarding its use to date. our hypothesis is that using the vessel sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. investigators propose a total sample size of 120 patients.

investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with plnd. the patients in our trial will be pelvic cancer patients at risk for lymphocele after plnd. given the safe nature of the product and the patient's risk for lymphocele after plnd and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. investigators intend to determine whether the rate of lymphocele formation after plnd at the time of robotic pelvic cancer surgery can be reduced by using the robotic vessel sealer unilaterally for the lymph node dissection. the side of the pelvis of each patient will be randomly selected by excel's® random number function "rand()" to receive the vessel sealer dissection. investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as bmi, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. in addition, dr. abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.

Eligibility criteria:
inclusion criteria: * age 18 or older * candidate scheduled to undergo robotic prostatectomy surgery with plnd exclusion criteria: * age \< 18 * unable to give informed consent * non-english speaking * not a candidate for robotic surgery for any reason

Keywords: prevention pelvic lymph node dissection lymphoceles prostate malignancies davinci vessel sealer endowrist one
impact of global care of the pain at chronic painful patients affected by cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. the results of this study will provide a new strategy of management of the patient's pain.

the majority of cystic fibrosis patients have chronic or intermittent pains. these pains have important consequences on the quality of life. currently, the treatment is essentially pharmacological (essentially paracetamol) but it is not enough in presence of of visual analogue scale (vas) \>4. in the study, the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. the sophrology is a dynamic method of physical and psychical relaxation. this aims are to decrease the pain, to decrease the anxiety and to improve the everyday life. this study will provide a new global strategy of the management of the patients' pain.

Eligibility criteria:
inclusion criteria: * cystic fibrosis patients defined by a test sweat and / or 2 pathogenic mutations * patients over 10 years * patients with pain symptoms (vas\> 4) recurrent (\> 4 episodes / month) or permanent since more than 6 months * agreement of patients, and parents (for children) for sophrology sessions conducted at home. * patient affiliated to social security exclusion criteria: * transplant patients or placed on a waiting list transplantation * patients had a patient-support by techniques hypnosis or relaxation therapy, during or within 3 months. * patients enrolled in another research interventional protocol. * women without contraception or pregnant.

Keywords: cystic fibrosis-pain-sophrology
hand eczema in the health care sector

Conditions: Hand Eczema

Summary: this project aims to investigate the prevalence of bacterial colonization and associated factors in health care workers with hand eczema with focus on staphylococcus aureus.

two groups will be examined in this study: health care workers with he and matched controls invited through a questionnaire study which will be sent to approximately 4000 health care workers in capital region. samples from health care workers with and without hand eczema will be collected after obtaining their written informed consent. collection of samples: swabs will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating hand and from the nostrils. the swabs will immediately be stored in -80 c° (research biobank) for subsequent analysis at statens serum institute.

Eligibility criteria:
inclusion criteria: * the diagnosis of hand eczema (for group with hand eczema) exclusion criteria: * other skin diseases (in both groups)
ketamine for older adults pilot

Conditions: Treatment Resistant Depression; Refractory Depression; Therapy-Resistant Depression; Late Life Depression; Geriatric Depression

Summary: this pilot study will assess the safety and feasibility of intravenous (iv) ketamine in older adults with treatment-resistant depression (trd). in addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment.

participants in this study will receive ketamine infusions twice a week for 4 weeks (acute phase). participants who respond or remit will continue with an additional 4 weeks of weekly ketamine infusions (continuation phase). participants will be assessed at baseline, end of acute phase, and end of continuation phase for effectiveness, safety, and executive functioning. participants will be asked to complete daily surveys of their depression symptoms during their participation.

Eligibility criteria:
inclusion criteria: 1. community-living men and women age 65 years and older; 2. treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by scid-5) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or triiodothyronine 3. persistent moderate to severe depressive symptoms determined by patient health questionnaire 9-item (phq-9)26 score ≥15 at baseline 4. able to provide informed consent. exclusion criteria: 1. dementia per history, score \< 24 on the montreal cognitive assessment (moca), or determined by clinical interview with geriatric psychiatrist to have high likelihood of dementia; 2. psychotic spectrum or bipolar disorder or severe personality disorder that at the pis discretion would interfere with safe participation. anxiety disorders are not an exclusion. 3. unstable medical conditions such that iv ketamine is not safe or tolerated or that would interfere with participation in a long-term study (i.e., poorly controlled hypertension, life expectancy \< 1 year because of terminal illness, unstable angina). 4. baseline systolic bp \> 165 systolic or 100 diastolic at evaluation. 5. current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., pcp). 6. use of naltrexone, memantine, or any medication that could be considered contraindicated with ketamine. 7. taking more than 2 adequately-dosed oral antidepressants. 8. high acute risk for suicide and unable to be managed safely in the clinical trial.

Keywords: ketamine
optimization of antiretroviral therapy

Conditions: HIV Infections

Summary: the combination antiretroviral therapy (cart) inhibit hiv replication effectively. however, synergy among these drugs has not been well considered. the dose of drugs used as monotherapy is the same as that used in combination therapy. tenofovir+lamivudine+efavirenz is still the first line regimen of cart in developing countries. the side effects of these drugs are related to the concentration of drugs. based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.


Eligibility criteria:
inclusion criteria: * hiv antibody positive * chinese nationality * naïve to antiretroviral therapy * willing to start antiretroviral therapy * provision of written informed consent exclusion criteria: * pregnant, breastfeeding, or lactating * females try to get pregnant during the research period * subjects who allergic to any of the research drugs * subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs * any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. this would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy * medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol * laboratory blood values: * haemoglobin \<9.0 grams/decilitre (g/dl) * neutrophil count \<1500/mm3 * platelet count \<75,000/mm3 * aspartate aminotransferase or alanine transaminase \>3 times upper limit of normal (uln) * total bilirubin \>3 times upper limit of normal (uln) * subjects with an estimated creatinine clearance of \<90 ml/minute
a study to evaluate the efficacy of valsartan/simvastatin combinations in patients with both essential hypertension and hypercholesterolemia

Conditions: Essential Hypertension; Hypercholesterolemia

Summary: the purpose of this study is to provide data on the dose response of simvastatin in lowering ldl-c when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. the primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in ldl-c.


Eligibility criteria:
inclusion criteria: * elevated ldl-cholesterol * essential hypertension exclusion criteria: * severe hypertension * prior or known muscular or neuromuscular disease of any type * a history of cardiovascular disease * hypertension or hypercholesterolemia due to secondary causes * uncontrolled diabetes or insulin treatment * evidence of hepatic or renal disease other protocol-defined exclusion criteria may apply

Keywords: valsartan simvastatin hypertension hypercholesterolemia angiotensin ii receptor blocker
comparing continuous subcutaneous insulin infusion with multiple daily injections to reach hba1c targets in children and adolescents with type 1 diabetes

Conditions: Diabetes Mellitus Type 1

Summary: this study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (csii ) therapy with a new insulin pump system with multiple daily injections (mdi) therapy. furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the accu-chek insight insulin pump.


Eligibility criteria:
inclusion criteria: * children and adolescents at least 24 months of age, and not more than 17 years of age at screening * diagnosed with type 1 diabetes * diagnosis of type 1 diabetes established \> 6 months before study start if \>5 years of age * indication for insulin pump therapy according to local guidelines * subject's most recent hba1c is equal or above 7.0% (53.0 mmol/mol) - measured at last assessment before screening within the past 2 months prior to the baseline visit into the study * willingness to use automated bolus advice obtained from the accu-chek insight diabetes therapy system during the study * willingness and ability to participate and comply with study procedures exclusion criteria: * disease or condition that in the opinion of the investigator is likely to affect compliance or the ability to complete the study * not willing or able to start insulin pump therapy * not willing to self-measure blood glucose at least four times daily * significantly impaired awareness of hypoglycemia * more than one hospitalization for severe hypoglycemia during the last 12 months * history of recurrent ketoacidosis during intensive insulin therapy * known strong plaster incompatibility and/or allergy * unstable chronic disease other than diabetes (e.g. impaired hepatic function, impaired renal function, impaired cardiac function, uncontrolled vascular complications) and any other condition interfering with the study procedures, as per investigator´s discretion. * if on antihypertensive, thyroid, anti-depressant or lipid-lowering medication, lack of stability on the medication for the past 2 months prior to the baseline visit in the study * chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy * prescription medications other than insulin interfering with diabetes management * acute illness or abnormality (e.g. impaired vision, impaired motor function, acute pain) at the time of screening interfering with study procedures, affecting compliance, or the ability to complete the study as per investigator´s discretion * either pregnant or breastfeeding * drug dependency * dependency on sponsor or investigator (e.g. co-worker or family member)